10000, 25000 hard enteric capsules pancreatic powder

Read this leaflet carefully. It contains information that is important to you.

  • Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
  • You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

In this leaflet: 
1. What Creon is and what it is used for 
2. What you need to know before you use Creon 
3. How to take Creon 
4. Possible side effects 
5. How to store Creon 
6. Contents of the packaging and other information 

1. What Creon is and what it is used for

Creon contains pancreatic powder, which is an enzyme mixture. The enzymes are extracted from the pancreas of pigs.

Pancreatic powder helps your body break down fat, starch, and protein in the food you eat as it passes through your intestines. In order for the pancreatin to mix properly with the food, it is enclosed in small pellets.

Creon is used to treat insufficient pancreatic function ( exocrine pancreatic insufficiency ) with poor absorption of nutrients from the intestine

2. What you need to know before using Creon

Do not use Creon

– if you are allergic to pancreatic powder, porcine protein, or any of the other ingredients of this medicine (listed in section 6).

Ask your doctor or pharmacist if you are unsure.

Warnings and cautions

– if you have cystic fibrosis (metabolic disorder) and have unusual or altered symptoms from the stomach consult a doctor. A rare condition in the gut called fibrotic coagulopathy, in which your gut is constricted, has been reported in patients with cystic fibrosis taking high doses of pancreatic powder enzyme products.

Creon with food and drink

Always take Creon during or immediately after a meal. This allows the enzymes to mix properly with the food and break it down as it passes through the intestine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Data from the treatment of pregnant women are missing.

Creon can be used during breast-feeding.

Driving and using machines

Creon has no or negligible effect on the ability to drive and use machines.

Creon contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

3. How to take Creon

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor who adapts it individually for you. Dosage one depends on the severity of the disease and the composition of the diet.

The usual dosage for patients with insufficient pancreatic function:

Children with or without cystic fibrosis:

  • under 4 years: 1000 lipase units per kilogram body weight per meal as starting dose.
  • over 4 years: 500 lipase units per kilogram body weight per meal as starting dose.

Adults: Dose one for a meal ranges between 25,000 to 80,000 lipase units and half that dose for snacks.

Adults with cystic fibrosis: 500 lipase units per kilogram body weight per meal as starting dose.

Always take Creon during or immediately after a meal. This allows the enzymes to mix properly with the food and break it down as it passes through the intestine.

The capsules should be swallowed whole with sufficient fluid and must not be crushed or chewed.

If you have difficulty swallowing the capsules whole, open them gently and mix the pellets with a small amount of soft acidic food that does not need to be chewed or mix them with an acidic liquid. Acidic soft foods can e.g. be apple puree or yogurt. The acidic liquid can be an apple, orange, or pineapple juice.

Swallow the mixture immediately, without crushing or chewing the pellets, and drink water or juice.

If the pellets are mixed with non-acidic food or liquid, crushed or chewed, it can lead to irritation in the mouth or change the way Creon works in the body.

Do not keep Creon capsules or their contents in your mouth.

Do not store the solution.

A general rule is to drink plenty of fluids every day. Adequate fluid intake during treatment is important. Too little fluid intake can worsen constipation.

If you forget to take Creon

If you forget to take a dose, take your next dose at the usual time, with the next meal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Creon

Do not stop taking Creon without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Creon can cause side effects, although not everybody gets them.

The most commonly reported adverse reactions were disorders of the gastrointestinal tract. Gastrointestinal disorders may be related to the disease for which you are using Creon.

The following side effects have been reported with this medicine:

Very common (affects more than 1 user in 10): abdominal pain (abdomen).

Common (affects more than 1 user in 100): diarrhea, constipation, nausea, vomiting, distended stomach.

Uncommon (affects less than 1 user in 100): skin rash.

No known frequency (can not be calculated from the available data): severe itching, hives ( urticaria ).

Other severe hypersensitivity reactions may be caused by Creon, signs of which may be anaphylactic shock, difficulty breathing, or swollen lips.

Scarring or thickening of the intestinal wall, called fibrotic coagulopathy, has been reported in patients with cystic fibrosis taking high doses of pancreatic powder products.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Creon

Do not store above 25 ° C. After opening, store at a maximum of 25 ° C and use within 6 months. Close packaging tightly. Moisture sensitive.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the can after EXP. date. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is pancreatic powder.

1 capsule Creon 10000 contains 150 mg of pancreatic powder, equivalent to:

Lipase 10000 Ph. Eur. devices

Amylase 8000 Ph. Eur. devices

Proteas 600 Ph. Eur. devices

1 capsule Creon 25000 contains 300 mg of pancreatic powder, equivalent to:

Lipase 25000 Ph. Eur. devices

Amylase 18000 Ph. Eur. devices

Proteas 1000 Ph. Eur. devices

The other ingredients are macrogol, hypromellose phthalate, cetyl alcohol, triethyl citrate, dimethicone, gelatin, iron oxide (See below), titanium dioxide (E171), sodium lauryl sulfate.

Creon 10000: Red, yellow, and black iron oxide (E172)

Creon 25000: Red and yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

Creon 10000: Two-tone capsule with brown lid and transparent base. The capsule is filled with enteric pellets (mini microspheres).

Creon 25000: Two-tone capsule with reddish-brown lid and transparent base. The capsule is filled with enteric pellets (mini microspheres).

Pack sizes:

Creon 10000: 100 pcs and 250 pcs.

Creon 25000: 100 st.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

BGP Products AB

Box 23033

104 35 Stockholm

Manufacturer:

Abbott Laboratories GmbH

Justus-von Liebig-Strasse 33

31535 Neustadt

Germany

Muhammad Nadeem

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